Last updated on June 2019

An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Participants Who Have Progressed on Crizotinib

Brief description of study

The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small-cell lung cancer (NSCLC) who have progressed on crizotinib as evidenced by progression free survival as assessed by a blinded independent review committee (BIRC) utilizing response evaluation criteria in solid tumors (RECIST) v1.1.

Detailed Study Description

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK-positive NSCLC.

The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK-positive NSCLC. Both drugs belong to a class of drugs called ALK inhibitors. Both drugs are taken by mouth. Both drugs are approved by the US FDA.

The study will enroll approximately 246 patients. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

Brigatinib Alectinib

All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT03596866

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Recruitment Status: Open

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